Regulation 17 Assessment of request for approvalF1

(1)

Where the licensing authority and an ethics committee receive a valid request for approval—

(a)

the licensing authority must assess the request for authorisation in relation to the clinical trial to which the request for approval relates;

(b)

the ethics committee must assess the application for an ethics committee opinion in relation to the clinical trial to which the request for approval relates.

(2)

The licensing authority—

(a)

must consider the safety of the clinical trial and the safeguarding of clinical trial participants; and

(b)

may have regard to whether the sponsor has failed to comply with regulation 25(1) or 25(2)(a) in relation to another clinical trial, and not rectified that failure.

(3)

The ethics committee must consider—

(a)

whether the anticipated benefits to participants and other individuals or groups affected by the medical condition under investigation outweigh the anticipated risks and inconveniences, taking account of—

(i)

the risks to the health of any of the participants posed by the medical condition for which the product is being investigated, and

(ii)

the nature of the intervention compared to normal clinical care; and

(b)

the measures used to—

(i)

seek and obtain informed consent for participation in the trial, and

(ii)

protect and promote the interests of participants and the general public (including by promoting transparency in research).

(4)

Where the request for approval contains a statement under regulation 16(2)(b) confirming that the trial is a notifiable trial, the licensing authority may, if it considers appropriate and without undertaking further assessment, rely on that statement to provide an authorisation of the clinical trial to which the request for approval relates.

(5)

The ethics committee may consider, and give an opinion on, any other issue relating to the clinical trial, if—

(a)

the committee has been asked by the sponsor to consider the issue;

(b)

it is, in the committee’s opinion, relevant to the other matters considered by the committee in accordance with paragraph (3).

(6)

The ethics committee may, before giving its opinion, obtain expert advice on any field which relates to the clinical trial.

(7)

If the licensing authority or the ethics committee considers it appropriate to do so, they may consult either or both of the following—

(a)

a relevant committee;

(b)

a specialist group or committee.

(8)

The authorities must not approve a clinical trial involving products for gene therapy if the use of those products in that trial would result in modifications to any participant’s germ line genetic identity.

Annotations

Textual amendments

F1: Regs. 14-26 substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 14